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1. Adjuvant Gemcitabine Versus Neoadjuvant/Adjuvant FOLFIRINOX in Resectable Pancreatic Cancer: The Randomized Multicenter Phase II NEPAFOX Trial

Author

Goetze, Thorsten O., Reichart, Alexander, Bankstahl, Ulli S., Pauligk, Claudia, Loose, Maria, Kraus, Thomas W., Elshafei, Moustafa, Bechstein, Wolf O., Trojan, Jörg, Behrend, Matthias, Homann, Nils, Venerito, Marino, Bohle, Wolfram, Varvenne, Michael, Bolling, Claus, Behringer, Dirk M., Kratz-Albers, Karsten, Siegler, Gabriele M., Hozaeel, Wael, and Al-Batran, Salah-Eddin

Published
2024
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2. ASO Visual Abstract: Adjuvant Gemcitabine Versus Neoadjuvant/Adjuvant FOLFIRINOX in Resectable Pancreatic Cancer—The Randomized Multicenter Phase II NEPAFOX Trial

Author

Goetze, Thorsten O., Reichart, Alexander, Bankstahl, Ulli S., Pauligk, Claudia, Loose, Maria, Kraus, Thomas W., Elshafei, Moustafa, Bechstein, Wolf O., Trojan, Jörg, Behrend, Matthias, Homann, Nils, Venerito, Marino, Bohle, Wolfram, Varvenne, Michael, Bolling, Claus, Behringer, Dirk M., Kratz-Albers, Karsten, Siegler, Gabriele M., Hozaeel, Wael, and Al-Batran, Salah-Eddin

Published
2024
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3. Q-HAM: a multicenter upfront randomized phase II trial of quizartinib and high-dose Ara-C plus mitoxantrone in relapsed/refractory AML with FLT3-ITD

Author

Jaramillo, Sonia, Le Cornet, Lucian, Kratzmann, Markus, Krisam, Johannes, Görner, Martin, Hänel, Mathias, Röllig, Christoph, Wass, Maxi, Scholl, Sebastian, Ringhoffer, Mark, Reichart, Alexander, Steffen, Björn, Kayser, Sabine, Mikesch, Jan-Henrik, Schaefer-Eckart, Kerstin, Schubert, Jörg, Geer, Thomas, Martin, Sonja, Kieser, Meinhard, Sauer, Tim, Kriegsmann, Katharina, Hundemer, Michael, Serve, Hubert, Bornhäuser, Martin, Müller-Tidow, Carsten, and Schlenk, Richard F.

Published
2023
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4. Elotuzumab, lenalidomide, bortezomib, dexamethasone, and autologous haematopoietic stem-cell transplantation for newly diagnosed multiple myeloma (GMMG-HD6): results from a randomised, phase 3 trial

Author

Adrian, Nicole, Bernhard, Helga, Böck, Hans-Peter, Bolling, Claus, Dingeldein, Gerrit, Emde, Till-Oliver, Ferstl, Barbara, Fietz, Thomas, Fronhoffs, Stefan, Fuhrmann, Stephan, Fuxius, Stefan, Geer, Thomas, Görner, Martin, Guenther, Barbara, Hartmann, Frank, Heilmeier, Bernhard, Heinsch, Michael, Hoffmann, Martin, Holderried, Tobias A.W., Klein, Stefan, Klump, Martin, Knauf, Wolfgang, La Rosée, Paul, Lange, Elisabeth, Lindemann, Walter, Lopez, Roderico, Mayer, Frank, Nückel, Holger, Papesch, Eva, Procaccianti, Maria, Reichart, Alexander, Rummel, Mathias, Scheuer, Lars, Schmitt, Hans-Roland, Staib, Peter, Steiniger, Heike, Tischler, Hans-Joachim, Ulshöfer, Thomas, Verbeek, Walter, Wacker, Alexander, Zirpel, Iris, Mai, Elias K, Goldschmidt, Hartmut, Miah, Kaya, Bertsch, Uta, Besemer, Britta, Hänel, Mathias, Krzykalla, Julia, Fenk, Roland, Schlenzka, Jana, Munder, Markus, Dürig, Jan, Blau, Igor W, Huhn, Stefanie, Hose, Dirk, Jauch, Anna, Kunz, Christina, Mann, Christoph, Weinhold, Niels, Scheid, Christof, Schroers, Roland, von Metzler, Ivana, Schieferdecker, Aneta, Thomalla, Jörg, Reimer, Peter, Mahlberg, Rolf, Graeven, Ullrich, Kremers, Stephan, Martens, Uwe M, Kunz, Christian, Hensel, Manfred, Benner, Axel, Seidel-Glätzer, Andrea, Weisel, Katja C, Raab, Marc S, and Salwender, Hans J

Published
2024
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5. Elotuzumab, lenalidomide, bortezomib, dexamethasone, and autologous haematopoietic stem-cell transplantation for newly diagnosed multiple myeloma (GMMG-HD6): results from a randomised, phase 3 trial

Author

Mai, Elias K, primary, Goldschmid, Hartmut, additional, Miah, Kaya, additional, Bertsch, Uta, additional, Besemer, Britta, additional, Hänel, Mathias, additional, Krzykalla, Julia, additional, Fenk, Roland, additional, Schlenzka, Jana, additional, Munder, Markus, additional, Dürig, Jan, additional, Blau, Igor W, additional, Huhn, Stefanie, additional, Hose, Dirk, additional, Jauch, Anna, additional, Kunz, Christina, additional, Mann, Christoph, additional, Weinhold, Niels, additional, Scheid, Christof, additional, Schroers, Roland, additional, von Metzler, Ivana, additional, Schieferdecker, Aneta, additional, Thomalla, Jörg, additional, Reimer, Peter, additional, Mahlberg, Rolf, additional, Graeven, Ullrich, additional, Kremers, Stephan, additional, Martens, Uwe M, additional, Kunz, Christian, additional, Hensel, Manfred, additional, Benner, Axel, additional, Seidel-Glätzer, Andrea, additional, Weisel, Katja C, additional, Raab, Marc S, additional, Salwender, Hans J, additional, Adrian, Nicole, additional, Bernhard, Helga, additional, Böck, Hans-Peter, additional, Bolling, Claus, additional, Dingeldein, Gerrit, additional, Emde, Till-Oliver, additional, Ferstl, Barbara, additional, Fietz, Thomas, additional, Fronhoffs, Stefan, additional, Fuhrmann, Stephan, additional, Fuxius, Stefan, additional, Geer, Thomas, additional, Görner, Martin, additional, Guenther, Barbara, additional, Hartmann, Frank, additional, Heilmeier, Bernhard, additional, Heinsch, Michael, additional, Hoffmann, Martin, additional, Holderried, Tobias A.W., additional, Klein, Stefan, additional, Klump, Martin, additional, Knauf, Wolfgang, additional, La Rosée, Paul, additional, Lange, Elisabeth, additional, Lindemann, Walter, additional, Lopez, Roderico, additional, Mayer, Frank, additional, Nückel, Holger, additional, Papesch, Eva, additional, Procaccianti, Maria, additional, Reichart, Alexander, additional, Rummel, Mathias, additional, Scheuer, Lars, additional, Schmitt, Hans-Roland, additional, Staib, Peter, additional, Steiniger, Heike, additional, Tischler, Hans-Joachim, additional, Ulshöfer, Thomas, additional, Verbeek, Walter, additional, Wacker, Alexander, additional, and Zirpel, Iris, additional

Published
2024
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6. Histopathological regression after neoadjuvant docetaxel, oxaliplatin, fluorouracil, and leucovorin versus epirubicin, cisplatin, and fluorouracil or capecitabine in patients with resectable gastric or gastro-oesophageal junction adenocarcinoma (FLOT4-AIO): results from the phase 2 part of a multicentre, open-label, randomised phase 2/3 trial

Author

Al-Batran, Salah-Eddin, Hofheinz, Ralf D, Pauligk, Claudia, Kopp, Hans-Georg, Haag, Georg Martin, Luley, Kim Barbara, Meiler, Johannes, Homann, Nils, Lorenzen, Sylvie, Schmalenberg, Harald, Probst, Stephan, Koenigsmann, Michael, Egger, Matthias, Prasnikar, Nicole, Caca, Karel, Trojan, Jörg, Martens, Uwe M, Block, Andreas, Fischbach, Wolfgang, Mahlberg, Rolf, Clemens, Michael, Illerhaus, Gerald, Zirlik, Katja, Behringer, Dirk M, Schmiegel, Wolff, Pohl, Michael, Heike, Michael, Ronellenfitsch, Ulrich, Schuler, Martin, Bechstein, Wolf O, Königsrainer, Alfred, Gaiser, Timo, Schirmacher, Peter, Hozaeel, Wael, Reichart, Alexander, Goetze, Thorsten O, Sievert, Mark, Jäger, Elke, Mönig, Stefan, and Tannapfel, Andrea

Published
2016
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7. CabaGast: multicentre, Phase II study with cabazitaxel in previously treated patients with advanced or metastatic adenocarcinoma of the esophagogastric junction and stomach

Author

Schmalenberg, Harald, Al-Batran, Salah-Eddin, Pauligk, Claudia, Zander, Thomas, Reichart, Alexander, Lindig, Udo, Kleiß, Mathias, Müller, Lothar, Bolling, Claus, Seufferlein, Thomas, Reichardt, Peter, Kullmann, Frank, Eschenburg, Henning, Schmittel, Alexander, Egger, Matthias, Block, Andreas, and Goetze, Thorsten Oliver

Published
2018
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8. Quizartinib and High-dose Ara-C plus Mitoxantrone in Relapsed/Refractory AML with FLT3-ITD

Author

Jaramillo, Sonia, primary, Cornet, Lucian Le, additional, Kratzmann, Markus, additional, Krisam, Johannes, additional, Görner, Martin, additional, Hänel, Mathias, additional, Röllig, Christoph, additional, Wass, Maxi, additional, Scholl, Sebastian, additional, Ringhoffer, Mark, additional, Reichart, Alexander, additional, Steffen, Björn, additional, Kayser, Sabine, additional, Mikesch, Jan-Henrik, additional, Schaefer-Eckart, Kerstin, additional, Schubert, Jörg, additional, Geer, Thomas, additional, Martin, Sonja, additional, Kieser, Meinhard, additional, Sauer, Tim, additional, Kriegsmann, Katharina, additional, Hundemer, Michael, additional, Serve, Hubert, additional, Bornhäuser, Martin, additional, Müller-Tidow, Carsten, additional, and Schlenk, Richard F., additional

Published
2022
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9. Clinical Validation of MCL35 in Mantle Cell Lymphoma Patients ≥65 Years Receiving Bendamustine-Rituximab

Author

Rosenthal, Allison C., primary, Ramsower, Colleen, additional, Mwangi, Raphael, additional, Maurer, Matthew J., additional, Villa, Diego, additional, McDonnell, Timothy J., additional, Feldman, Andrew L., additional, Habermann, Thomas M., additional, Cohen, Jonathon B., additional, Robetorye, Ryan S., additional, Campo, Elías, additional, Giné, Eva, additional, Cook, James R., additional, Hill, Brian T., additional, Raess, Philipp, additional, Ott, German, additional, Reichart, Alexander, additional, Scott, David W., additional, and Rimsza, Lisa M., additional

Published
2021
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10. Quality of life and outcome of patients with metastatic pancreatic cancer receiving first‐line chemotherapy with nab‐paclitaxel and gemcitabine: Real‐life results from the prospective QOLIXANE trial of the Platform for Outcome, Quality of Life and Translational Research on Pancreatic Cancer registry

Author

Al‐Batran, Salah‐Eddin, Hofheinz, Ralf‐Dieter, Reichart, Alexander, Pauligk, Claudia, Schönherr, Caroline, Schlag, Rudolf, Siegler, Gabriele, Dörfel, Steffen, Koenigsmann, Michael, Zahn, Mark‐Oliver, Schubert, Jörg, Aldaoud, Ali, Höffkes, Heinz‐Gert, Schulz, Holger, Hahn, Lars, Uhlig, Jens, Blau, Wolfgang, Stauch, Martina, Weniger, Jörg, Wolf, Martin, Jacobasch, Lutz, Bildat, Stephan, Wehmeyer, Jürgen, Homann, Nils, Trojan, Jörg, Waidmann, Oliver, Fietz, Thomas, Feustel, Hans‐Peter, Groschek, Matthias, Wierecky, Jan, Waibel, Karin, Mahlmann, Stefan, Schwindel, Uwe, Peters, Uwe, Schuch, Gunter, Pink, Daniel, Eschenburg, Henning, Wörns, Marcus‐A., Harich, Hans‐Detlev, Weikersthal, Ludwig Fischer, Däßler, Klaus‐Ulrich, Behringer, Dirk M., Messmann, Helmut, Kretzschmar, Albrecht, Gallmeier, Eike, Forstbauer, Helmut, Kunzmann, Volker, Papke, Jens, Büchner‐Steudel, Petra, Vehling‐Kaiser, Ursula, Springfeld, Christoph, Vogel, Arndt, Ettrich, Thomas J., Schaaf, Marina, Hausen, Gerrit zur, and Götze, Thorsten Oliver

Published
2021

11. Randomized multicenter phase II/III study with adjuvant gemcitabine versus neoadjuvant/adjuvant FOLFIRINOX in resectable pancreatic cancer: The NEPAFOX trial.

Author

Al-Batran, Salah-Eddin, primary, Reichart, Alexander, additional, Bankstahl, Ulli Simone, additional, Pauligk, Claudia, additional, Kraus, Thomas Werner, additional, Bechstein, Wolf Otto, additional, Trojan, Jorg, additional, Behrend, Matthias, additional, Potenberg, Jochem, additional, Homann, Nils, additional, Venerito, Marino, additional, Bohle, Wolfram, additional, Varvenne, Michael, additional, Bolling, Claus, additional, Behringer, Dirk M., additional, Kratz-Alber, Karsten, additional, Siegler, Gabriele Margareta, additional, Hozaeel, Wael, additional, and Goetze, Thorsten Oliver, additional

Published
2021
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12. Real-life results from the prospective QoliXane trial of the platform for outcome, quality of life, and translational research on pancreatic cancer (PARAGON) registry.

Author

Al-Batran, Salah-Eddin, primary, Hofheinz, Ralf Dieter, additional, Reichart, Alexander, additional, Pauligk, Claudia, additional, Schlag, Rudolf, additional, Siegler, Gabriele Margareta, additional, Hoeffkes, Heinz-Gert, additional, Blau, Wolfgang, additional, Homann, Nils, additional, Trojan, Jorg, additional, Waidmann, Oliver, additional, Pink, Daniel, additional, Messmann, Helmut, additional, Kunzmann, Volker, additional, Vogel, Arndt, additional, Ettrich, Thomas Jens, additional, Schoenherr, Caroline, additional, Schaaf, Marina, additional, zur Hausen, Gerrit, additional, and Goetze, Thorsten Oliver, additional

Published
2020
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13. Perioperative chemotherapy for locally advanced, resectable gastric or gastro-oesophageal junction adenocarcinoma (FLOT4): a randomised, phase 2/3 trial

Author

Al-Batran, Salah-Eddin, Homann, Nils, Pauligk, Claudia, Goetze, Thorsten O, Meiler, Johannes, Kasper, Stefan, Kopp, Hans-Georg, Mayer, Frank, Haag, Georg Martin, Luley, Kim, Lindig, Udo, Schmiegel, Wolff, Pohl, Michael, Stoehlmacher, Jan, Folprecht, Gunnar, Probst, Stephan, Prasnikar, Nicole, Fischbach, Wolfgang, Mahlberg, Rolf, Trojan, Jörg, Koenigsmann, Michael, Martens, Uwe M, Thuss-Patience, Peter, Egger, Matthias, Block, Andreas, Heinemann, Volker, Illerhaus, Gerald, Moehler, Markus, Schenk, Michael, Kullmann, Frank, Behringer, Dirk M, Heike, Michael, Pink, Daniel, Teschendorf, Christian, Löhr, Carmen, Bernhard, Helga, Schuch, Gunter, Rethwisch, Volker, von Weikersthal, Ludwig Fischer, Hartmann, Jörg T, Kneba, Michael, Daum, Severin, Schulmann, Karsten, Weniger, Jörg, Belle, Sebastian, Gaiser, Timo, Oduncu, Fuat S, Güntner, Martina, Hozaeel, Wael, Reichart, Alexander, Jäger, Elke, Kraus, Thomas, Moenig, Stefan Paul, Bechstein, Wolf O, Schuler, Martin, Schmalenberg, Harald, Hofheinz, Ralf D, and FLOT4-AIO Investigators

Subjects
Adult, Male, Antineoplastic Combined Chemotherapy Protocols/administration & dosage/therapeutic use, Fluorouracil/administration & dosage/therapeutic use, Docetaxel/administration & dosage/therapeutic use, Administration, Oral, urologic and male genital diseases, Disease-Free Survival, Stomach Neoplasms/drug therapy/pathology, Humans, neoplasms, Digestive System Surgical Procedures, Aged, Neoplasm Staging, Aged, 80 and over, ddc:617, Esophagogastric Junction/pathology, organic chemicals, Cisplatin/administration & dosage/therapeutic use, Middle Aged, digestive system diseases, Treatment Outcome, Oxaliplatin/administration & dosage/therapeutic use, Adenocarcinoma/drug therapy/pathology, Female, Leucovorin/administration & dosage/therapeutic use, therapeutics, Capecitabine/administration & dosage/therapeutic use
Abstract

Docetaxel-based chemotherapy is effective in metastatic gastric and gastro-oesophageal junction adenocarcinoma. This study reports on the safety and efficacy of the docetaxel-based triplet FLOT (fluorouracil plus leucovorin, oxaliplatin and docetaxel) as a perioperative therapy for patients with locally advanced, resectable tumours.

Published
2019

14. Perioperative chemotherapy with fluorouracil plus leucovorin, oxaliplatin, and docetaxel versus fluorouracil or capecitabine plus cisplatin and epirubicin for locally advanced, resectable gastric or gastro-oesophageal junction adenocarcinoma (FLOT4): a randomised, phase 2/3 trial

Author

Al-Batran, Salah-Eddin, primary, Homann, Nils, additional, Pauligk, Claudia, additional, Goetze, Thorsten O, additional, Meiler, Johannes, additional, Kasper, Stefan, additional, Kopp, Hans-Georg, additional, Mayer, Frank, additional, Haag, Georg Martin, additional, Luley, Kim, additional, Lindig, Udo, additional, Schmiegel, Wolff, additional, Pohl, Michael, additional, Stoehlmacher, Jan, additional, Folprecht, Gunnar, additional, Probst, Stephan, additional, Prasnikar, Nicole, additional, Fischbach, Wolfgang, additional, Mahlberg, Rolf, additional, Trojan, Jörg, additional, Koenigsmann, Michael, additional, Martens, Uwe M, additional, Thuss-Patience, Peter, additional, Egger, Matthias, additional, Block, Andreas, additional, Heinemann, Volker, additional, Illerhaus, Gerald, additional, Moehler, Markus, additional, Schenk, Michael, additional, Kullmann, Frank, additional, Behringer, Dirk M, additional, Heike, Michael, additional, Pink, Daniel, additional, Teschendorf, Christian, additional, Löhr, Carmen, additional, Bernhard, Helga, additional, Schuch, Gunter, additional, Rethwisch, Volker, additional, von Weikersthal, Ludwig Fischer, additional, Hartmann, Jörg T, additional, Kneba, Michael, additional, Daum, Severin, additional, Schulmann, Karsten, additional, Weniger, Jörg, additional, Belle, Sebastian, additional, Gaiser, Timo, additional, Oduncu, Fuat S, additional, Güntner, Martina, additional, Hozaeel, Wael, additional, Reichart, Alexander, additional, Jäger, Elke, additional, Kraus, Thomas, additional, Mönig, Stefan, additional, Bechstein, Wolf O, additional, Schuler, Martin, additional, Schmalenberg, Harald, additional, and Hofheinz, Ralf D, additional

Published
2019
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16. Real life data of 601 patients from the QoliXane pancreatic cancer study.

Author

Schoenherr, Caroline, primary, Goetze, Thorsten Oliver, additional, zur Hausen, Gerrit, additional, Reichart, Alexander, additional, Pauligk, Claudia, additional, Schlag, Rudolf, additional, Siegler, Gabriele Margareta, additional, Doerfel, Steffen, additional, Aldaoud, Ali, additional, Hahn, Lars, additional, Schubert, Joerg Ernst Albert, additional, Zahn, Mark-Oliver, additional, Hoeffkes, Heinz-Gert, additional, Reiser, Marcel, additional, Koenigsmann, Michael, additional, Blau, Wolfgang, additional, Uhlig, Jens, additional, Homann, Nils, additional, Trojan, Jorg, additional, and Al-Batran, Salah-Eddin, additional

Published
2018
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17. FOLFIRI plus ramucirumab versus paclitaxel plus ramucirumab for patients with advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction as second-line therapy: The RAMIRIS study.

Author

Lorenzen, Sylvie, primary, Thuss-Patience, Peter C., additional, Pauligk, Claudia, additional, Goekkurt, Eray, additional, Ettrich, Thomas Jens, additional, Lordick, Florian, additional, Reichardt, Peter, additional, Stahl, Michael, additional, Kopp, Hans-Georg, additional, Hegewisch-Becker, Susanna, additional, Reichart, Alexander, additional, Alguel, Hana, additional, Bichev, Dmitry, additional, Kestler, Angelika, additional, Hacker, Ulrich, additional, Ziegenhagen, Nicolas Stephan, additional, Mueller, Christian, additional, Hermes, Barbara, additional, and Al-Batran, Salah-Eddin, additional

Published
2018
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18. CabaGast: multicentre, Phase II study with cabazitaxel in previously treated patients with advanced or metastatic adenocarcinoma of the esophagogastric junction and stomach

Author

Schmalenberg, Harald, primary, Al-Batran, Salah-Eddin, additional, Pauligk, Claudia, additional, Zander, Thomas, additional, Reichart, Alexander, additional, Lindig, Udo, additional, Kleiß, Mathias, additional, Müller, Lothar, additional, Bolling, Claus, additional, Seufferlein, Thomas, additional, Reichardt, Peter, additional, Kullmann, Frank, additional, Eschenburg, Henning, additional, Schmittel, Alexander, additional, Egger, Matthias, additional, Block, Andreas, additional, and Goetze, Thorsten Oliver, additional

Published
2017
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19. A multicentre, phase II study with cabazitaxel in previously treated patients with advanced or metastatic adenocarcinoma of the oesophagogastric junction and stomach (CABAGAST).

Author

Schmalenberg, Harald, Pauligk, Claudia, Zander, Thomas, Reichart, Alexander, Lindig, Udo, Kleiss, Mathias, Mueller, Lothar, Bolling, Claus, Seufferlein, Thomas, Reichardt, Peter, Kullmann, Frank, Eschenburg, Henning, Schmittel, Alexander, Egger, Matthias, Block, Andreas, Al-Batran, Salah-Eddin, Goetze, Thorsten Oliver, Schmalenberg, Harald, Pauligk, Claudia, Zander, Thomas, Reichart, Alexander, Lindig, Udo, Kleiss, Mathias, Mueller, Lothar, Bolling, Claus, Seufferlein, Thomas, Reichardt, Peter, Kullmann, Frank, Eschenburg, Henning, Schmittel, Alexander, Egger, Matthias, Block, Andreas, Al-Batran, Salah-Eddin, and Goetze, Thorsten Oliver

Published
2017

20. A multicentre, phase II study with cabazitaxel in previously treated patients with advanced or metastatic adenocarcinoma of the oesophagogastric junction and stomach (CABAGAST).

Author

Schmalenberg, Harald, primary, Pauligk, Claudia, additional, Zander, Thomas, additional, Reichart, Alexander, additional, Lindig, Udo, additional, Kleiss, Mathias, additional, Müller, Lothar, additional, Bolling, Claus, additional, Seufferlein, Thomas, additional, Reichardt, Peter, additional, Kullmann, Frank, additional, Eschenburg, Henning, additional, Schmittel, Alexander, additional, Egger, Matthias, additional, Block, Andreas, additional, Al-Batran, Salah-Eddin, additional, and Goetze, Thorsten Oliver, additional

Published
2017
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21. Nab-paclitaxel/gemcitabine first-line therapy in patients with metastatic pancreatic carcinoma and high-bilirubin levels: Data from the German QoliXane Pancreatic Cancer Registry.

Author

zur Hausen, Gerrit, primary, Waidmann, Oliver, additional, Woerns, Marcus A., additional, Hoeffkes, Heinz-Gert, additional, Doerfel, Steffen, additional, Zahn, Mark-Oliver, additional, Aldaoud, Ali, additional, Stauch, Martina, additional, Springfeld, Christoph, additional, Haertel, Nicolai, additional, Reichart, Alexander, additional, Pauligk, Claudia, additional, Roemmler-Zehrer, Josefine, additional, Hofheinz, Ralf, additional, and Al-Batran, Salah-Eddin, additional

Published
2016
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22. Evaluation of clinical parameters and biomarkers in older, untreated mantle cell lymphoma patients receiving bendamustine-rituximab.

Author

Ramsower CA, Rosenthal A, Robetorye RS, Mwangi R, Maurer M, Villa D, McDonnell T, Feldman A, Cohen JB, Habermann T, Campo E, Clot G, Bühler MM, Kulis M, Martin-Subero JI, Giné E, Cook JR, Hill B, Raess PW, Beiske KH, Reichart A, Hartmann S, Holte H, Scott D, and Rimsza L

Subjects
Adult, Humans, Aged, Rituximab adverse effects, Bendamustine Hydrochloride therapeutic use, Biomarkers, Prognosis, Antineoplastic Combined Chemotherapy Protocols adverse effects, Lymphoma, Mantle-Cell pathology
Abstract

Mantle cell lymphoma (MCL) is clinically and biologically heterogeneous. While various prognostic features have been proposed, none currently impact therapy selection, particularly in older patients, for whom treatment is primarily dictated by age and comorbidities. Herein, we undertook a comprehensive comparison of clinicopathological features in a cohort of patients 60 years and older, uniformly treated with bendamustine and rituximab, with a median survival of >8 years. The strongest prognostic indicators in this cohort were a high-risk call by a simplified MCL international prognostic index (s-MIPI) (HR: 3.32, 95% CI: 1.65-6.68 compared to low risk), a high-risk call by MCL35 (HR: 10.34, 95% CI: 2.37-45.20 compared to low risk) and blastoid cytology (HR: 4.21, 95% CR: 1.92-9.22 compared to classic). Patients called high risk by both the s-MIPI and MCL35 had the most dismal prognosis (HR: 11.58, 95% CI: 4.10-32.72), while those with high risk by either had a moderate but clinically relevant prognosis (HR: 2.95, 95% CI: 1.49-5.82). A robust assay to assess proliferation, such as MCL35, along with stringent guidelines for cytological evaluation of MCL, in combination with MIPI, may be a strong path to risk-stratify older MCL patients in future clinical trials., (© 2023 British Society for Haematology and John Wiley & Sons Ltd.)

Published
2024
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23. Quality of life and outcome of patients with metastatic pancreatic cancer receiving first-line chemotherapy with nab-paclitaxel and gemcitabine: Real-life results from the prospective QOLIXANE trial of the Platform for Outcome, Quality of Life and Translational Research on Pancreatic Cancer registry.

Author

Al-Batran SE, Hofheinz RD, Reichart A, Pauligk C, Schönherr C, Schlag R, Siegler G, Dörfel S, Koenigsmann M, Zahn MO, Schubert J, Aldaoud A, Höffkes HG, Schulz H, Hahn L, Uhlig J, Blau W, Stauch M, Weniger J, Wolf M, Jacobasch L, Bildat S, Wehmeyer J, Homann N, Trojan J, Waidmann O, Fietz T, Feustel HP, Groschek M, Wierecky J, Waibel K, Mahlmann S, Schwindel U, Peters U, Schuch G, Pink D, Eschenburg H, Wörns MA, Harich HD, von Weikersthal LF, Däßler KU, Behringer DM, Messmann H, Kretzschmar A, Gallmeier E, Forstbauer H, Kunzmann V, Papke J, Büchner-Steudel P, Vehling-Kaiser U, Springfeld C, Vogel A, Ettrich TJ, Schaaf M, Hausen GZ, and Götze TO

Subjects
Adult, Aged, Aged, 80 and over, Albumins therapeutic use, Deoxycytidine analogs & derivatives, Deoxycytidine therapeutic use, Female, Humans, Male, Middle Aged, Paclitaxel therapeutic use, Registries, Treatment Outcome, Gemcitabine, Adenocarcinoma drug therapy, Antineoplastic Combined Chemotherapy Protocols adverse effects, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Pancreatic Neoplasms drug therapy, Quality of Life
Abstract

Few data exist on health-related quality of life (QoL) in patients with metastatic pancreatic cancer (mPC) receiving first-line chemotherapy (Awad L ZE, Mesbah M Boston, MA. Applying survival data methodology to analyze quality of life data, in Mesbah M, Cole BF, Ting Lee M-L (eds): Statistical Methods for Quality of Life Studies: Design, Measurements and Analysis. Kluwer Academic Publishers 2002). The QOLIXANE study is a prospective, noninterventional, multicenter substudy of the Platform for Outcome, Quality of Life and Translational Research on Pancreatic Cancer (PARAGON) registry, which evaluated QoL in patients with mPC receiving first-line gemcitabine and nab-paclitaxel chemotherapy in real-life setting. QoL was prospectively measured via EORTC QLQ-C30 questionnaires at baseline and every month thereafter. Therapy and efficacy parameters were prospectively collected. Main objectives were the rate of patients without deterioration of Global Health Status/QoL (GHS/QoL) at 3 and 6 months. Six hundred patients were enrolled in 95 German study sites. Median progression-free survival was 5.9 months (95% confidence interval [CI], 5.2-6.3). Median overall survival (OS) was 8.9 months (95% CI, 7.9-10.2), while median time to deterioration of GHS/QoL was 4.7 months (95% CI, 4.0-5.6). With a baseline GHS/QoL score of 46 (SD, 22.8), baseline QoL of the patients was severely impaired, in most cases due to loss in role functioning and fatigue. In the Kaplan-Meier analysis, 61% and 41% of patients had maintained GHS/QoL after 3 and 6 months, respectively. However, in the QoL response analysis, 35% and 19% of patients had maintained (improved or stable) GHS/QoL after 3 and 6 months, respectively, while 14% and 9% had deteriorated GHS/QoL with the remaining patients being nonevaluable. In the Cox regression analysis, GHS/QoL scores strongly predicted survival with a hazard ratio of 0.86 (P < .0001). Patients with mPC have poor QoL at baseline that deteriorates within a median of 4.7 months. Treatment with gemcitabine and nab-paclitaxel is associated with maintained QoL in relevant proportions of patients. However, overall, results remain poor, reflecting the aggressive nature of the disease., (© 2020 Union for International Cancer Control.)

Published
2021
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